Clinical trial · Interventional
Living Well With Brain Cancer: A Group-Based Intervention to Promote Whole-Person Well-Being
Pilot Study of the Living Well With Brain Cancer Intervention
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The goal of this clinical trial is to learn if the newly designed group self-management program is feasible to conduct and improves mental and behavioral health outcomes compared to a control group in people diagnosed with brain cancer. The main questions it aims to answer are: * Is it feasible to conduct this program? * Does the new group self-management program improve behavioral health outcomes more than in the control group that will not be in a group setting?
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Brain Cancer | Malignant Brain Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Educational Materials Only | Other | — | UNRESOLVED |
| Group Self-Management Sessions | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Group Self-Management Arm
- description
- Participants in the intervention arm will attend eight 90-minute virtual group sessions with nurse and peer educators that will navigate them through the different self-management content.
- interventionNames
- Behavioral: Group Self-Management Sessions
- type
- ACTIVE_COMPARATOR
- label
- Education Only Arm
- description
- Participants in this arm will be invited to use an online learning management system to access the educational materials. There are no group sessions, and there are no nurse or peer educators that will lead the participants through the materials.
- interventionNames
- Other: Educational Materials Only
Primary outcomes (1)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Currently living in the United States * Aged 18 years or older * Confirmed diagnosis of a malignant brain tumor including diffuse gliomas, World Health Organization (WHO) grades II, III, and IV (either by directly sharing their pathology report or confirmation from their prescribing treating provider) * Treating prescribing provider who follows regularly with participant Exclusion Criteria: * \<1 month since initial diagnosis and/or \<1 month since surgical resection * Enrollment in hospice * Significant physical or cognitive disabilities that prohibit involvement using our clinician's judgement as a self-management expert, with consultation with personal clinician if needed * Currently receiving psychiatric treatment for a serious mental illness (e.g., schizophrenia) * Not able to communicate in English at a conversational level
References
Publications (55)
- BACKGROUNDKrippendorff K. Content analysis: An introduction to its methodology. Sage publications; 2013.
- BACKGROUNDStemler S. An overview of content analysis. Practical Assessment. Research & Evaluation. 2001;7(17): 137-146.
- BACKGROUNDGruber-Baldini AL, Velozo C, Romero S, Shulman LM. Validation of the PROMIS(R) measures of self-efficacy for managing chronic conditions. Qual Life Res. 2017 Jul;26(7):1915-1924. doi: 10.1007/s11136-017-1527-3. Epub 2017 Feb 26. PMID 28239781
- BACKGROUNDGabel N, Altshuler DB, Brezzell A, Briceno EM, Boileau NR, Miklja Z, Kluin K, Ferguson T, McMurray K, Wang L, Smith SR, Carlozzi NE, Hervey-Jumper SL. Health Related Quality of Life in Adult Low and High-Grade Glioma Patients Using the National Institutes of Health Patient Reported Outcomes Measurement Information System (PROMIS) and Neuro-QOL Assessments. Front Neurol. 2019 Mar 15;10:212. doi: 10.3389/fneur.2019.00212. eCollection 2019. PMID 30930834
- BACKGROUNDGershon RC, Lai JS, Bode R, Choi S, Moy C, Bleck T, Miller D, Peterman A, Cella D. Neuro-QOL: quality of life item banks for adults with neurological disorders: item development and calibrations based upon clinical and general population testing. Qual Life Res. 2012 Apr;21(3):475-86. doi: 10.1007/s11136-011-9958-8. Epub 2011 Aug 27. PMID 21874314
- BACKGROUNDBunevicius A. Reliability and validity of the SF-36 Health Survey Questionnaire in patients with brain tumors: a cross-sectional study. Health Qual Life Outcomes. 2017 May 4;15(1):92. doi: 10.1186/s12955-017-0665-1. PMID 28472964
- BACKGROUNDBlixen C, Perzynski A, Kanuch S, Dawson N, Kaiser D, Lawless ME, Seeholzer E, Sajatovic M. Training peer educators to promote self-management skills in people with serious mental illness (SMI) and diabetes (DM) in a primary health care setting. Prim Health Care Res Dev. 2015 Apr;16(2):127-37. doi: 10.1017/S1463423614000176. Epub 2014 Apr 7.